Supplementing DHA in growth-restricted very preterm infants
Early DHA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
NA · University of Alabama at Birmingham · NCT06207071
This study is testing if giving a special fatty acid called DHA to very preterm babies who are not growing well can help their brain growth without causing them to gain too much fat.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 24 Hours to 72 Hours |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06207071 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of early enteral supplementation of docosahexaenoic acid (DHA) in very preterm infants who are growth-restricted. The study aims to determine whether this supplementation can enhance head growth without negatively impacting fat mass accretion. A total of 152 infants will be randomly assigned to receive either DHA or a control treatment, with outcomes measured over the initial weeks of life. The trial addresses a critical gap in nutritional practices for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are very preterm infants born between 22 and 32 weeks of gestation with a birth weight below the 25th percentile.
Not a fit: Patients with major congenital or chromosomal anomalies or those with terminal illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve growth outcomes and overall health in very preterm infants who are at risk of malnutrition.
How similar studies have performed: While the approach of DHA supplementation is promising, it remains to be seen if this specific method will yield successful outcomes, as similar studies have shown mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational ages between 22 0/7 - 32 6/7 weeks gestation * \< 25th centile birthweight Exclusion Criteria: * Major congenital/chromosomal anomalies * Terminal illness in which decisions to withhold or limit support have been made
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Study coordinator: Ariel A Salas, MD, MSPH
- Email: asalas@uab.edu
- Phone: 205-934-4680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition, Premature, Nutrition Disorder, Infant